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NCT05964803 Clinical Trial

Lower Urinary Tract Symptoms in Males Living With HIV

Lower Urinary Tract Symptoms Clinical Trial

Official title:
Males Living With HIV and LUTS: A Case-control Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05964803
Other study ID # KocUrol5
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date January 1, 2024

Study information
Verified date April 2024
Source Koç University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The primary aim of this study is to learn whether the frequency of lower urinary tract symptoms differ between the males with seronegativity for HIV and males living with HIV.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date January 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients above 18 years old Exclusion Criteria: - Non-Turkish speakers - Previous surgeries or medications for lower urinary tract symptoms

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Questionnaires
MLWH and control groups were asked to complete the following questionnaires: International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS), ICIQ-Short Form (ICIQ-SF), International Prostate Symptom Score (IPSS), King's Healthcare Questionnaire (KHQ), 8-item Overactive Bladder Questionnaire (OAB-V8), Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).

Locations
Country Name City State
Turkey Koc University Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Koç University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Questionnaire 1 International Consultation on Incontinence Questionnaire Day 1
Primary Questionnaire 2 Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) Day 1
Primary Questionnaire 3 ICIQ-Short Form (ICIQ-SF) Day 1
Primary Questionnaire 4 International Prostate Symptom Score (IPSS) Day 1
Primary Questionnaire 5 King's Healthcare Questionnaire (KHQ) Day 1
Primary Questionnaire 6 8-item Overactive Bladder Questionnaire (OAB-V8) Day 1
Primary Questionnaire 7 Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7). Day 1
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